APO-GLIMEPIRIDE glimepiride 4mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glimepiride

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

Glimepiride

Authorization status:

Registered

Patient Information leaflet

APO- GLIMEPIRIDE - Consumer Medicine Information
Page 1 of 6
APO- GLIMEPIRIDE
_glimepiride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-
GLIMEPIRIDE. It does not contain
all of the available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits this medicine is
expected to have for you.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT APO- GLIMEPIRIDE
IS USED FOR
_ _
The name of your medicine
is
APO-GLIMEPIRIDE. It contains
the
active ingredient,
glimepiride.
It is used to control blood
glucose
in patients with Type II
diabetes
mellitus.
This type of diabetes is
also
known as
non-insulin-dependent
diabetes mellitus (NIDDM)
or
maturity onset
diabetes.
Glimepiride is used when diet
and
exercise are not enough
to
control
your blood
glucose.
Glimepiride can be used alone, or
together with insulin or other
medicines for treating diabetes.
_HOW IT WORKS _
Glimepiride belongs to a group
of
medicines called
sulphonylureas.
Glimepiride lowers high
blood
glucose by increasing the
amount
of insulin produced by
your
pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose).
Hypoglycaemia (low blood
glucose) can occur suddenly.
Signs may include:
•
Weakness, trembling or
shaking
•
Sweating
•
Lightheadedness,
dizziness, headache or
lack of concentration
•
Tearfulness or crying
•
Irritability
•
Hunger
•
Numbness around the lips
and tongue
If not treated prompted, these may
progress to:
•
Loss of co-ordination
•
Slurred speech
•
Confusion
•
Loss of consciousness or
seizures
Hyperglycaemia (high blood
glucose) usually occurs more
slowly than low blood glucose.
Signs of high blood glucose may
incl

Summary of Product characteristics

APO-GLIMEPIRIDE TABLETS- Product Information
Page 1 of 10
PRODUCT INFORMATION
APO-GLIMEPIRIDE
NAME OF THE MEDICINE
APO-Glimepiride
AUSTRALIAN APPROVED NAME
Glimepiride
CHEMICAL STRUCTURE
APO-Glimepiride tablets contain glimepiride which is a member of the
sulfonylurea group of oral
antidiabetic agents.
Chemical Name:
_trans_-1-{4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]-
phenylsulfonyl}-3-(4-methylcyclohexyl)urea.
Structural Formula:
Molecular Formula:
C
24
H
34
N
4
O
5
S
Molecular Weight:
490.63
CAS Registry Number:
93479-97-1
DESCRIPTION
Glimepiride is a white odourless, crystalline powder, practically
insoluble in methanol and water, slightly
soluble in ethanol and sparingly soluble in methylene chloride.
Each APO-Glimepiride tablet contains glimepiride as active ingredient
and the excipients: lactose,
microcrystalline cellulose, sodium starch glycollate, povidone,
magnesium stearate, iron oxide red (1
mg tablets only), iron oxide yellow (2 mg and 3 mg tablets only) and
indigo carmine (2 mg and 4 mg
tablets only).
PHARMACOLOGY
PHARMACODYNAMICS
_Mechanism of Action _
_ _
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood
glucose concentrations. The
primary mechanism of action of glimepiride appears to be dependent on
stimulating the release of insulin
from functioning pancreatic beta cells. Glimepiride acts in concert
with glucose by improving the
sensitivity of beta cells to physiological glucose stimulus, resulting
in insulin secretion in the rhythm of
meals. In addition, extrapancreatic effects (e.g. reduction of basal
hepatic glucose production and
increased peripheral tissue sensitivity to insulin and glucose uptake)
may also play a limited role in the
activity of glimepiride.
APO-GLIMEPIRIDE TABLETS- Product Information
Page 2 of 10
In nonfasting diabetic patients, the hypoglycaemic action of a single
dose of glimepiride persists for 24
hours.
Evidence from _in vitro_ and animal studies suggests that there is
lower glucagon secretion with glimepiride
than glibenclami